International Alliance for Biological Standardization

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9th Annual IABS Statistics Workshop

Statistical Innovation Advancing CMC

November 2023

The impact of statistics in Chemistry, Manufacturing & Control (CMC) is constantly expanding, and CMC Statisticians & Data Scientists are key players in developing, commercializing, and maintaining medical products.

There are multiple aspects within this ever-evolving framework that are of highest relevance for the CMC area: Improving and developing innovative statistical methodologies to address unmet needs, addressing questions regarding CMC statistics arising from yet unexplored modalities or technologies, advancing the regulatory framework to provide guidance, as well as the actual implementation and the life-cycle management of developed statistical solutions.

This conference provides a forum for discussing and further exploring opportunities to harmonize approaches as well as mediate between all these different aspects.

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